CRYoablation for Small Tumors As Local Treatment - SIX Trial

LRR was defined as recurrence in the ipsilateral breast or chest wall, as well as in the ipsilateral axillary, supraclavicular/infraclavicular region, or internal mammary lymph nodes detected during follow-up, regardless of whether distant metastasis occurred before, after, or simultaneously.

A cost-minimization analysis is an economic technique used to compare the costs of different interventions or treatments that produce equivalent outcomes in terms of efficacy and clinical effects. In other words, this analysis is applied when treatments are assumed to have the same clinical effectiveness, and the goal is to determine which one has the lowest cost. It is a type of cost-effectiveness analysis that compares only the costs of two or more technologies, as the health effects resulting from the compared technologies are considered similar. Clinical outcomes will not be taken into account. We will calculate the costs by collecting data on both direct and indirect expenses associated with the treatments. Direct costs will include procedure-related expenses such as equipment, supplies, medical fees, associated tests and consultations, hospitalization costs if applicable, and medication use. Indirect costs, if a societal perspective is considered, will include factors such as ti

LRR was defined as recurrence in the ipsilateral breast or chest wall, as well as in the ipsilateral axillary, supraclavicular/infraclavicular region, or internal mammary lymph nodes detected during follow-up, regardless of whether distant metastasis occurred before, after, or simultaneously.

DFS is defined as the time from procedure to time of ipsilateral recurrence, contralateral recurrence, regional recurrence or distant metastasis, or date of last follow-up if none of the recurrence events occur.

OS is defined as the time from the date of first dose to the date of death due to any cause.

CTCs are tumor cells that have sloughed off the primary tumor and extravasate into and circulate in the blood. Blood samples will be collected from participants included in the study at the time of the procedure, at 6 months, and at 1 year. A total of 10 mL of blood will be drawn via peripheral venipuncture into EDTA tubes (BD Vacutainer®), which will be maintained under homogenization for up to 6 hours at room temperature until filtration is performed (ISET®; Rarecells Diagnostics, Paris, France). CTCs will be identified through cytopathological analysis. After filtration, membranes washed with PBS and air-dried will be stored at -20°C until analysis. Blood samples for CTC research will preferably be sent within 48 hours and no later than 72 hours to the coordinating center.

Patient satisfaction will be assessed using the Breast-Q questionnaire, a validated tool designed to measure patient-reported outcomes related to breast surgery and treatment.

Quality of life will be assessed using the EQ-5D questionnaire. The EQ-VAS (Visual Analogue Scale) thermometer is a component of the EQ-5D, a standardized instrument for measuring health-related quality of life. In the EQ-VAS, patients evaluate their own health status at a given moment using a numerical scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.